Device for umbilicus protection during abdominal surgery

ABSTRACT

A device and system for umbilicus protection during abdominal surgery; and, especially plastic reconstructive and aesthetic surgery requiring Umbilicoplasty and/or umbilicus transposition is provided. The device embodies an umbilicus shield, which envelops the Umbilicus during abdominal surgery. The device includes a tubular element, having a distal end and a proximal end, containing near its proximal end, means for releasable retaining suture material from tacking stitches taken in the umbilicus to provide means for drawing the Umbilicus into the tubular element. The suture material is advantageously drawn through the tubular element by means of a suture shuttle which contains, proximate its distal end, means for releasable retaining the suture material. The device facilitates umbilicoplasty and umbilicus transposition during abdominal surgery; prevents nicks or cuts during circum umbilicus dissection; prevents nicks, cuts, or amputation of the umbilicus during defattening and/or abdominal flap dissection; reduces the possibility of Umbilical Pedicel strangulation during Rectus Abdominis Musculoaponeurotic Plication; and indicates the exact location of the Umbilicus for the new umbilical orifice during umbilical transportation.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application having Ser. No. 10/715,097, filed Nov. 17, 2003 for “Method and System for Umbilicus Protection During Abdominal Surgery”. The complete disclosure of the related application is hereby incorporated by reference herein.

BACKGROUND

The present system relates generally to a device for use in abdominal subcutaneous surgery. In recent years elective cosmetic surgery has become more prevalent. With the constant pressure on society to look and act younger, plastic surgeons and dermatologists have derived many youth enhancing medical procedures. For example, removing wrinkles, breast augmentation, liposuction to remove excessive fat, and the like has come into accepted vogue. Although these procedures are usually relatively risk free, complications can cause sever medical problems and even, in some cases, death. Among these complications are infections, skin loss, blood loss, strangulation of circulation, and the like.

Some of these elective procedures are relatively simple and require little patient preparation and are relatively risk free. Examples are Botox® injections, skin peels, certain laser procedures, and the like. These procedures are usually performed in the physician's office or a clinic, on an outpatient basis; and, are accompanied by minor discomfort and pain. Other elective procedures, however, involve major invasive surgery, requiring general anesthesia, hospitalization, and a rather extended recovery period. Face-lifts, some extensive liposuction, and breast augmentation are among those procedures. Procedures such as these and some others involve extensive subcutaneous invasion, blood loss, extended operating room time, pain management, and an extensive recovery period.

Recently, even more radical procedures have been introduced to affect cosmetic appearance. Women, especially after childbirth, develop abdominal disfigurement, such as stretch marks, excessive skin sagging, and the like. In addition, the abdomen, which contains substantial fat cells, tends to enlarge with weight gain disproportionately to the remainder of the anatomy in both men and women. Further, with dramatic weight loss, the abdomen skin cannot return to its former “stretched” configuration, resulting in skin folds or sagging at the lower abdomen. In order to deal with this problem, a procedure known as abdominoplasty, commonly referred to as a “tummy tuck,” has been developed.

Abdominoplasty involves the removal of excess skin and fat from the middle and lower abdomen as well as tightening of the abdominal (rectus) muscles. More specifically, this operation is done to tighten the loose skin of the abdomen and repair the weak muscles of the abdominal wall. The procedure is sometimes combined with liposuction to, for example, remove fat, smooth the edges, and improve the contour. If the patient suffers from obesity, the panniculus of fat is removed at the same time.

Although abdominoplasty varies, and can even be accomplished, in some cases, by endoscopic methods, however, a “complete abdominoplasty” involves invasive procedures following basically the same steps. First, a lower abdomen incision is made. The Abdominal Flap is then lifted and the underlying fat is removed to the abdominal fascia. The abdominal wall muscles are tightened by suturing, then the flap is stretched with excess skin being removed, and then the flaps are sutured, preferably below the panty line. The procedure can be “complete” or “partial (mini).” A partial abdominoplasty may take as little as an hour or two, while the complete abdominoplasty takes between two to five hours, depending on the extent of work required.

In a partial abdominoplasty, a short incision is made, and the transposition of the umbilicus (umbiliplasty) is usually not required. The skin is then separated only between the incision line and the umbilicus. This Abdominal Flap is stretched down, while any excess skin is removed. Finally, the Abdominal Flap is then stitched back into place. In partial abdominoplasty significant strides have been made in surgical procedure using endoscopic assisted methods. One such procedure is disclosed in U.S. Pat. No. 5,655,544 issued in August 1997 to G. W. Johnson. In accordance with this method, the use of abdominal incisions is minimized leaving substantially no visible scars on the abdomen of the patient.

The endoscope assisted abdominoplasty uses two small hidden incisions, one in the umbilicus or on the abdomen or in pre-existing scars or other areas (such as under the armpit) for introduction of the surgical instruments, and a small incision within the pubic hair line for endoscopic and/or direct observation and control of the procedure. While observing the procedure through the endoscope, the surgical instruments are inserted through the umbilical incision to remove fat by liposuction and plicate and repair the muscles by use of a tenaculum and fascial sutures. After removal of the instruments, the small incisions are sutured, and the skin layer is allowed to retract and tighten.

While these procedures have met with a modicum of success, they do not lend themselves to performing a “complete” abdominoplasty. This is primarily due to the fact that a complete abdominoplasty usually requires an umbilicoplasty (repositioning of the belly button). The complete procedure involves making a long incision from one hipbone to the other above the pubic area. A second incision is made to free the navel from surrounding tissue (Circum Umbilical Pedicel dissection). Next, the skin and subcutaneous fat (abdominal flap) are separated from the abdominal wall to reveal the vertical abdominal muscles (rectus) for tightening. This tightening provides a firmer abdominal wall and helps to narrow the waistline. The Abdominal Flap is then stretched down and extra skin is removed. A new orifice (belly button hole) is cut for the Umbilicus, which is then stitched into place. Finally, the incisions are stitched, dressings are applied, and any excess fluids are drained from the surgical site.

Full or complete abdominoplasty, although an invasive procedure, is routinely performed in hospitals and clinics through-out the world. Even though this procedure has become, more or less, routine, it is fraught with a number of potential complications. Some of the more serious complications relate to the Umbilicus. The Umbilical skin (belly button) and Umbilical Pedicel (stem), to which the umbilical cord was originally attached, is connected to the abdominal fascia tissue and muscle and cannot be repositioned when the epidermis (skin) is repositioned. In order to lift the Abdominal Flap, remove underlying fatty tissue, and stretch the remaining tissue over the abdomen to remove excess skin, the umbilical orifice (belly button opening in the skin) must be repositioned to accommodate the Umbilicus, which does not move. Thus, when the Abdominal Flap is stretched and repositioned, a new belly button opening in the Abdominal Flap (skin) is required to access the Umbilicus.

In order to accomplish this during complete abdominoplasty, the Umbilicus must be cut from the surrounding skin by performing a Circum Umbilical Pedicel dissection. Then, scissors are used to dissect the Umbilical Pedicel from the surrounding fat and tissue down to the muscle fascia. The possibility for nicking or cutting the Umbilical Pedicel during this procedure is substantial.

Then an incision is made along the lower abdomen to facilitate lifting the Abdominal Flap from the abdomen to “defatten” the abdomen. This dissection is accomplished using, for example, a scalpel and/or electrocautery blade. The possibility for nicking, cutting, or even amputation of the Umbilical Pedicel during this procedure is substantial. Next, suturing on the midline (Rectus Abdominis Musculoaponeurotic Plication) tightens the abdominal fascia muscle. Umbilical Pedicle strangulation can occur during this suturing of the abdominal muscles. The separated Abdominal Flap is then stretched over the defattened abdomen and the access skin trimmed. A new belly button orifice is then cut into the skin after it is stretched and trimmed. Reinserting the Umbilicus in the new orifice can also lead to complications such as strangulation, caused by twisting the Umbilical Pedicel. Sutures are then placed at the incision line to hold the Umbilicus, as well as the stretched Abdominal Flap over the defattened abdomen.

Thus, the complete procedure is somewhat risky using this prior art technique. First, the Umbilical Pedicel can be cut or nicked during Circum Umbilical Pedicel Dissection, resulting in possible blood supply damage to the Umbilicus. Further, since defattening is accomplished under the skin, using a surgical blade, too much tissue may be removed while performing undermining of the flap resulting in nicking, cutting, or amputating the Umbilical Pedicel all together. Additionally, once the Umbilical Pedicel is released from the skin hooks (as described below); it must be re-determined prior to cutting a new orifice. It is difficult to determine the correct Umbilicus location under the subcutaneous fat layer for new umbilicus positioning during Umbilicus transposition (cutting a new belly button hole and palpating the Umbilicus through the new skin opening). Twisting of the Umbilical Pedicel can occur during Umbilicus transposition (placement of the Umbilical Pedicel into a new opening in abdomen skin) resulting in strangulation.

Therefore, it would be advantageous to have a system for facilitating Umbilicus positioning during abdominal surgery, and especially plastic reconstructive and aesthetic surgery requiring Umbilicoplasty and Umbilicus transposition. It would be further advantageous to have a device, which prevents nicks, or cuts of the Umbilicus during defattening, and assuring proper positioning of the opening during Umbilicoplasty and Umbilical Pedicle transposition as well as elimination of Umbilical Pedicel strangulation.

SUMMARY OF THE INVENTION

A system and device for protecting the Umbilicus during subcutaneous abdominal surgery comprises an Umbilicus shield comprising an open-ended vessel having a proximal and a distal end, which envelops the Umbilical and the Umbilical Pedicel during abdominal surgery. The Umbilicus is drawn into the vessel by means of suture material fastened to the Umbilical skin by, for example, a tacking suture drawn through the Umbilical skin. Advantageously, the Umbilicus shield comprises a tubular element. Advantageously, the Umbilicus shield contains, near its proximal end, means for releasabley retaining suture material drawn through the interior of the vessel from tacking stitches taken in the Umbilical skin to provide means for retaining and securing the Umbilicus within the Umbilicus Shield during surgery.

The system may further comprise a suture shuttle element, being adapted to be slidably inserted interior the Umbilicus shield and having a proximate and distal end. Advantageously, proximate suture shuttle element's distal end, there are positioned means for releasably retaining suture material adapted for use in drawing the suture material into the vessel. Advantageously, the means for releasabley retaining the sutures material comprises notches. In another embodiment, the means for releasably retaining the suture material comprises slanted notched portions having eyelets at the interior thereof which eyelets allow the suture material to slip there through for pulling the suture material through the Umbilicus shield.

In accordance with one embodiment, the notched portions of the Umbilicus shield are retained on opposing ears disposed peripherally of the proximal end of tubular element, such that the ears can be used to manipulate the Umbilicus shield during surgery. In accordance with another aspect the tubular member has a circular lip disposed upon the proximal end and an upstanding collar portion. The circular lip and the collar contain aligned, opposing notches to retain the suture material. In accordance with one aspect, the tubular element of the Umbilicus shield contains, on the proximal outer surface thereof, markings in relationship to the notched portions to orient the Umbilicus shield, relative to the sutures. Advantageously, these markings are black printed “UP” and “DOWN”, R (right) and L (left) wherein each is disposed in each quadrant of the tubular element, wherein UP marks the superior (upper) aspect of the midline on the patient; and, DOWN marks the inferior (bottom) aspect of the midline of the patient.

In accordance with another aspect of the instant invention, the distal end of the tubular element contains a Teflon® coated, electrocautery, cutting, ring-shaped blade to advantageously provide an electrocautery dissector for Umbilical Pedicel dissection down to the abdominal fascia. In operation, the tubular element so equipped is pushed straight down while simultaneously pulling the suture material taught. In accordance with this aspect, the electrical wires from the electrocautery blade to the energy source are isolated inside the tubular element to insulate it from the patient. Upon completion of Umbilical Pedicel dissection, the connectors to the energy source are disengaged.

In another advantageous embodiment, the Umbilicus shield is adjustable and telescoping comprising a vessel, preferably tubular, having, for example, a base element and a locking element so that the shield can be easily adjusted to the patient's panniculus of fat which is to be navigated during umbiliplasty. The adjustable and telescoping Umbilicus shield is advantageously tubular comprising a base element having a channel containing locking notches and locking element having a locking pin on the outside thereof for releasably matingly engaging the locking notches.

BRIEF DESCRIPTION OF THE FIGURES

The objects, features, and advantages of the present invention will be apparent to one skilled in the art, in view of the following detailed description in which:

FIG. 1 is an exploded view of one embodiment of the protective device showing the relationship of the tubular element and the suture shuttle element as the sutures are shuttled through the tubular element;

FIG. 2 is a side illustrational view of another embodiment of the tubular element;

FIG. 3A is a side view of another embodiment of the plunger type, suture shuttle element;

FIG. 3B is an end view of the plunger type, suture shuttle element of FIG. 3A;

FIG. 4 is an illustration of an initial circum umbilical incision;

FIG. 5 is an illustration of the initially circumcised Umbilicus showing placement of the tacking sutures;

FIG. 6 is an illustration of the dissected Umbilicus with tacking stitches and suture material;

FIG. 7 is an illustration of the suture shuttle element placement in the tubular element with suture material placement;

FIG. 8 is an illustration of the suture shuttle element as it is pulled out of the tubular element to seat the tubular element around the Umbilicus for dissection of the Umbilical Pedicel;

FIG. 9 is an illustration of the suture material as tensioned in the notched ears of the tubular element after Umbilical Pedicel dissection as placed for surgery;

FIG. 10 is an illustration of Abdominal Flap Dissection with the tensioned tubular element in place about the Umbilical Pedicel;

FIG. 11 is an illustration of the tubular element in place around the Umbilical Pedicel during rectus abdominis musculoaponeurotic plication;

FIG. 12 is a side view of FIG. 11 showing the placement of the tubular element;

FIG. 13 is an illustration of placement of a palpated new Umbilicus;

FIG. 14 is an illustration of another embodiment of the plunger type, suture shuttle element;

FIG. 15 is an illustration of a base tube containing retaining notches of an extendible tubular element in accordance with another embodiment of the system;

FIG. 16 is an illustration of the locking tube portion of the extendible tubular element in accordance with another embodiment of the system;

FIG. 17 is an illustration of the locking tube portion, inserted interior the base tube portion of the telescoping tubular element and locked in accordance with another embodiment of the system.

DISCUSSION OF THE SYSTEM NOMENCLATURE

As used herein, the following terms will have the meanings hereinafter set forth. Umbilicus means the totality of the place on the central abdomen where a narrow cord of tissue (umbilical cord) connected the developing embryo, or fetus, with the placenta for maternal nourishment. Umbilical skin means the top portion of the Umbilical Pedicel which protrudes through the skin (belly button). The Umbilical Pedicle (stem), the top portion of which is the Umbilical skin, is connected to the abdominal fascia tissue and muscle. Umbilicoplasty means a Circum-Umbilical Pedicle Dissection and transposition of the Umbilicus. Rectus muscle means the muscles forming the abdominal wall. Circum-Umbilical Pedicle Dissection means a circum Umbilical incision followed by a dissection of the Umbilical Pedicle from the surrounding tissue down to the abdomen fascia. Rectus Abdominis Musculoaponeurotic Plication means tightening of the rectus abdominis muscle by suturing along the midline. Abdominal Flap means the abdominal skin and under lying subcutaneous fat. Abdominal Flap Dissection means undermining the skin and subcutaneous fat.

DETAILED DESCRIPTION OF THE INVENTION

There is provided a system and device for Umbilicus protection during abdominal surgery; and, especially plastic reconstructive and aesthetic surgery requiring umbilicoplasty (belly button) revision surgery and/or Umbilical transposition. The system facilitates Umbilicoplasty, as well as the Umbilical transposition during abdominal surgery; prevents nicks or cuts during circum Umbilical Pedicle dissection; prevents nicks, cuts, or amputation of the Umbilical Pedicle during defattening and/or Abdominal Flap dissection; and, reduces the possibility of Umbilical pedicle strangulation during Rectus Abdominis Musculoaponeurotic Plication. Likewise, the system prevents such strangulation and assures proper alignment of the new orifice and Umbilicus during Umbilicus transpositions.

A system for Umbilicus protection during abdominal surgery, and particularly a surgical procedure where safe complete Circum Umbilical Dissection of the Umbilical Pedicle down to abdominal fascia needs to be performed, is provided. However, any abdominal surgery wherein the Umbilicus site is invaded is intended to be included in the instant system. The system and device are particularly advantageous in protecting the Umbilicus during abdominal subcutaneous surgery; however, they are particularly useful in plastic reconstructive and aesthetic surgery wherein Umbilicoplasty is performed as part of an abdominoplasty procedure. It will be realized by the skilled artisan that the following description is exemplary in nature and embodies advantageous ways of practicing the claimed invention, but is not exhaustive of the devices, which are available. As long as the Umbilical Pedicle is encased or enveloped within the protection or Umbilical shielding device, the advantages of the broad system are realized. For example, the encasing element need not be tubular and there need not be a shuttle component; however, these embodiments facilitate the practice of the invention.

In accordance with the method for utilization of the system during abdominal surgery wherein Umbilicoplasty is indicated, the Umbilicus is first circum dissected and then drawn into the Umbilicus shield. Exemplary of the use is as follows: the Umbilicus is first circum dissected; at least a pair of tacking sutures is secured to superior and inferior point of the midline of the Umbilicus; the suture shuttle is inserted through the tubular element; the suture material from the tacking sutures is placed through the notches in the distal end of the suture shuttle element to rest in the eyelet; the suture shuttle element is pulled through the tubular element while pushing the tubular element into the circum dissected incision to capture the Umbilicus interior the tubular element; the suture material is then tensioned to draw the Umbilical Pedicel within the tubular element and then attached to the tubular element such that the superior tacking suture corresponds to the “UP” position on the tubular element and the inferior tacking suture corresponds to the “DOWN” position on the tubular element. The pedicle can then be dissected to the abdominal fascia by cutting around the periphery of the tubular element.

In accordance with another aspect, the placed Umbilical shield protects the Umbilical Pedicel from possible blood supply damage or amputation during the Abdominal Flap undermining around the Umbilical Pedicel. In accordance with another aspect, the placed tubular element prevents Umbilical Pedicel strangulation by suturing during Rectus Abdominis Musculoaponeurotic Placation. In accordance with another aspect, the placed tubular element facilitates determination of correct Umbilicus location under the Abdominal Flap during Umbilicoplasty (palpating the tubular element including the opening). In accordance with another aspect, the placed tubular element having peripheral markings “UP,” “DOWN,” “L,” and “R” on the tubular element prevents the Umbilical Pedicel from twisting during new Umbilicus positioning and suturing and as result from strangulation and necrosis.

The method for using the device and system for Circum-Umbilical Dissection and proper positioning of the orifice during Umbilicoplasty and Umbilicus transposition includes the steps of subcutaneous suturing, at least at a superior and inferior point of the midline of the Umbilicus; securing the suture material to the distal end of the suture shuttle; pulling the suture material through the tubular element; and, securing the suture material to the proximal end of tubular element under suitable pressure to at least partially move the Umbilicus interior the tubular element and tension the distal end of the tubular element against the abdominal fascia.

In one aspect, the tubular element is used to provide a cutting dye during complete Circum-Umbilical Dissection to the abdominal fascia. In another aspect, the tubular element is used to provide protection for the Umbilical Pedicel during Abdominal Flap Dissection. In accordance with this aspect, the distal end of the tubular element is placed into the complete Circum-Umbilical Pedicel Dissection to rest on the abdominal fascia, while the sutures are tensioned to draw substantially the entire Umbilicus interior the tubular element. In accordance with another aspect, the tubular element is used to prevent strangulation of the pedicle during Rectus Abdominis Musculoaponeurotic Plication. In accordance with this embodiment, the distal end of the Umbilical Shield is maintained in tensioned contact with the abdominal fascia, surrounding the Umbilicus, during suturing of the abdominal muscle wall. The outer surface of the tubular element prevents the sutured muscle wall from strangling the Umbilical Pedicel.

In accordance with another aspect, the proximal end of the tubular element is used to facilitate Umbilicus transposition. In accordance with this aspect, the Abdominal Flap is pulled over the proximal end of the tubular element located beneath the Abdominal Flap. The skin is then dissected about the proximal end of the tubular element to provide the new orifice. In accordance with another aspect, the markings on the tubular element are positioned to prevent strangulation (twisting) of the Umbilical Pedicel during reattachment of the Umbilicus to the Abdominal Flap.

Turning to FIG. 1, there is shown device 10 for Umbilicus protection during subcutaneous abdominal surgery comprising a tubular element 12 and a plunger type, suture shuttle element 14. Tubular element 12 has a cylindrical housing 16 of sufficient inside diameter to house the Umbilical Pedicel when the tubular element 12 is tensioned in place. Tubular element 12 contains opposing ears 18 and 20, disposed upon the cylindrical housing 16 at its proximal end and containing notches 22 and 24, respectively, for releasabley frictionally engaging suture material 34 as will be later shown.

Suture shuttle element 14 has affixed to the top thereof a plunger type, circular knob 26. A set of ribbed portions 28 is connected on one end to the circular knob 26 and to an end plate 30 on the other. End plate 30 contains notches 32 spaced in each quadrant, as better shown in FIG. 3B. The ribbed portions 28 are adapted for guiding suture shuttle element 14 through the opening in tubular element 12. The ribbed portions 28 have an outside diameter of approximately the same dimension as the inside diameter of tubular element 12.

Turning to FIG. 2, there is shown another embodiment 100 of the tubular element 12 here designated as tubular element 112. Tubular element 112 has a cylindrical housing 116 of sufficient inside diameter to house the Umbilical Pedicel when the tubular element 112 is in place. Tubular element 112 contains a circular lip 118, disposed upon the proximal end of cylindrical housing 116 and contains opposing notches 122 and 124, respectively. Tubular element 112 also contains an upstanding, circular collar 154 elevated from the circular lip 118 and containing notches therein, which correspond to notches 122 and 124, all such notches being adopted for releasabley frictionally engaging suture material (not shown). It will be realized by the skilled artisan that tubular element 112 can be of various configurations including differing shapes, diameters and lengths. Advantageously, tubular element 112 contains marking on the outer diameter, at the proximal end, as shown, indicating UP, DOWN, LEFT (“L”), and RIGHT (“R”). The UP and DOWN nomenclature are coincident with notches 124 and 122, respectively.

Turning to FIG. 3A, there is shown another embodiment of suture shuttle element 14 designated as suture shuttle element 200. The suture shuttle element 200 has a narrowed neck portion 240, for ease of handling, and is connected on one end to the plunger type, circular knob 226 and to a circular guide plate 240 on the other. Ribbed portions 228 are narrowed at the neck 240 and extend the length of suture shuttle element 200, passing through guide plate 242 and terminate at end plate 230, which carries notches 232 as better shown in FIG. 3B. FIG. 3B is an end view of suture shuttle element 200 as shown in FIG. 3A. FIG. 3B shows the outline of plunger type circular knob 226 and end plate 230 with notches 232. The guide plate 242 and the end plate 230 have outside diameters approximate of the inside diameter of the tubular element to permit guided sliding of the suture shuttle element 200 within the tubular element ( 112 or 12).

In accordance with the invention, the tubular element can be made of any suitable material compatible with surgical procedures and advantageously latex free plastic. The tubular element is preferably sized in accordance with the surgery to be performed and physical attributes of the patient. It need not be circular. For example, lengths in the range of 6-8 cm have been found useful. Advantageously, the tubular element comes in varies sizes which are color coded for ease of use in the operating theater. For example:

-   -   Length Diameter     -   40 mm (yellow) 15 mm (yellow)     -   60 mm (green) 20 mm (green)     -   80 mm (red) 25 mm (red).

The tubular element wall thickness is sufficient to provide stability during surgical procedure, for example, about 1.5 mm. The proximal end of the tubular element can contain opposing “ears” on the peripheral surface, which provides a mechanism for inserting the tubular element through the circum umbilical incision in order for the distal end of the tubular element to rest on the abdominal fascia. Preferably, these ears are oppositely disposed, and are small enough so that they do not interfere with palpating the tubular element through the new orifice during Umbilicus transportation. The ears are preferably notched such as to bisect the tubular element and provide releasable securing for the strands of suture material as previously described. It will be realized that the tubular element does not need to carry the previously described ears. In this embodiment, the notch for releasabley securing the suture material can be directly carried in the tubular element, proximate the end wall.

In accordance with one aspect, the outer proximal end of the tubular element carries, advantageously, below the notched ears, markings “UP” (12 o'clock) and “DOWN” (6 o'clock). In the other quadrants (at 3 o'clock and 9 o'clock) are respectively markings “L” and “R.” In this manner, the initial placing of the tubular element, after pedicle dissection, is aligned with the mid-section of the patient (UP and DOWN), such that UP is proximate the patient's head and DOWN is proximate the patient's feet with, for example, left and right designating patient's left and right, or alternately, surgeon's right and left.

The suture shuttle element is advantageously of the same material as the tubular element, and contains a ribbed guide on its outer diameter. It is of the same lengthwise geometric shape as the tubular element. The outer diameter of the suture shuttle is of the same dimension as the inner diameter of the tubular element. The length of the suture shuttle element is advantageously greater than the tubular element, such that upon complete insertion of the suture shuttle element into the tubular element, the distal end of the suture shuttle element carrying the notches is exposed. The suture shuttle can, for example, be of three sizes according to the length and diameter of the tubular element so long as the suture shuttle element is of a length greater than that of the tubular element. The sizes are for example: 1.) 80 mm shuttle element for 40 mm tubular element; 2.) 100 mm shuttle element for 60 mm tubular element; and, 3.) 120 mm shuttle element for 80 mm tubular element.

At the distal end of each size suture shuttle are four notches for tacking suture material engaging and are advantageously located at 3, 6, 9 and 12 o'clock position. The distal end of the suture shuttle element contains a circular plate carrying the four peripheral notches for releasabley securing the strands of suture material as further described below. In one embodiment, the various tubular element diameters and lengths, as previously described, are color-coded with the corresponding suture shuttle element of the same color for use therewith. In this manner, during surgery the appropriate suture shuttle element can be instantaneously matched with the appropriate tubular element for a particular surgical scenario.

The suture material that can be used in accordance with the instant invention is preferably Ethibond® brand sutures, but only need to be of sufficient tensile strength to secure the distal end of the tubular element against the abdominal fascia through out the surgical procedure. It is used for tacking only and removed upon completion of the surgery.

In accordance with the method for utilizing the system, FIGS. 4 through 13 show the step-by-step procedure for use of the device of the instant invention during the performance of an abdominoplasty. For exemplary purposes only, the method of the instant invention will track an abdominoplasty, which begins, by circumcision of the Umbilicus as shown in FIG. 4. In accordance with FIG. 4, an umbiliplasty is shown. Skin hooks 40 and 42 lift Umbilicus 44 for dissection by scalpel 46 to perform a circum peripheral umbilical dissection 48. Once the dissection takes place, skin hooks 40 and 42 are removed and the Umbilicus 44 relaxes within the circum umbilical incision.

As shown in FIG. 5, tacking sutures 35 are taken on the dissected Umbilicus 44 at the superior (UP) and inferior (DOWN) positions. Sufficient suture material 34 is provided to allow tubular element 12 placement, as was described above. Turning to FIG. 6, there is shown preparation for tubular element attachment. The suture material 34, connected to the Umbilicus 44 by means of tacking stitches 35, is lifted to separate the Umbilicus 44 from Abdominal Flap 50. As shown in FIG. 7, the suture shuttle element 200 (or 14 depending on the embodiment used) is inserted into tubular element 12 such that suture shuttle element 200 protrudes beyond the distal end of cylindrical housing 16 exposing ribbed portion 228 and end plate 230 containing notches 232. The extended suture material 34 is placed within notches 232 as shown.

As seen in FIG. 8, the suture shuttle element 200 is pulled, by means of the plunger type, circular knob 226, to extract the suture shuttle element 200 from the tubular element 12 thereby pulling suture material 34 attached to end plate 230 through tubular element 12. Simultaneously, tubular element 12 is pushed down by means of ears 20 and 18 into circum umbilical incision 48. Tensioning on suture material 34 moves Umbilicus 44 within the interior of cylindrical housing 16, as shown in phantom. Likewise, the UP marking and the DOWN marking on tubular element 12 are aligned with the head of the patient and the feet of the patient respectively.

As seen in FIG. 9, placement of tubular element 12 is completed by removing suture material 34 from notches 232 in end plate 230 of suture shuttle element 200 and placing the suture material 34 in notches 24 and 22 in ears 20 and 18 respectively. As can be seen, Umbilicus 44 is retained within tubular element 12, and the distal end of tubular element 12 protrudes into circum umbilical incision 48 such that the complete stalk of Umbilicus 44 is protected and separated from Abdominal Flap 50. Dissection of the Umbilicus 44 is then accomplished by scalpel or scissors following the outer circumference of cylindrical housing 16 down to the abdominal fascia 56 while maintaining pressure on the ears 20 and 18 to seat the distal end of tubular element 12 on the abdominal fascia 56. Suture material 34 can then be re-tensioned in notches 22 and 24 as necessary to retain the entire stalk of Umbilicus 44 down to the abdominal fascia 56 within housing 16. When the tubular element 12 is in place and houses the dissected Umbilicus 44 in housing 16, by means of tensioned suture material 34 retained releasable engaging notches 22 and 24, the distal end of cylindrical housing 16 rests on abdominal fascia 56 and protrudes through Abdominal Flap 50 and through the subcutaneous fatty layer to protect the entirety of the stalk of Umbilicus 44.

As shown in FIG. 10, lateral abdominal incision 47 is then made to allow Abdominal Flap 50 to be lifted as shown. Because the stalk of Umbilicus 44 is protected via cylindrical housing 16, the stalk of Umbilicus 44 is protected from nicks, cuts, and even amputation from scalpel 46. As the Abdominal Flap 50 is lifted and de-fattened, abdominal fascia 56 is exposed. As Abdominal Flap 50 is lifted past the proximate end of the tubular element 12, it is allowed to slip through circum umbilical incision 48 by means of movement of, for example, retractor 54.

As better seen in FIG. 11, with Abdominal Flap 50 completely lifted, de-fattened, and held by retractors 54, midline musculoaponeurotic plication sutures 58 are taken with suture forceps 52 in performing Rectus Abdominis Musculoaponeurotic Placation. Because the cylindrical housing 16 completely envelops the stalk of Umbilicus 44, the tubular element 12 prevents strangulation of the Umbilical Pedicel by the musculoaponeurotic plication midline sutures 58.

better seen in FIG. 12, the abdominal fascia 56 bears the musculoaponeurotic plication midline sutures 58, but the sutured abdominal fascia 56 is separated from the Umbilicus stalk 44 by means of cylindrical housing 16 while the superior and inferior Umbilicus 44 positioning is maintained by alignment of the markings (UP, DOWN, R, and L) to prevent “twist-type” strangulation, which in the prior art procedure could not be readily detected. It will be realized by those skilled in the art that the original umbilical orifice is removed with excess abdominal skin below the lateral abdominal incision line 47 (not shown). When the Abdominal Flap 50 is “re-draped,” the excess skin is excised at the lateral abdominal incision 47 with tension on the Abdominal Flap 50.

FIG. 13 shows the Umbilicus transposition in accordance with one aspect of the invention. The tubular element 12 helps to determine exactly the correct new umbilical orifice position, as shown in phantom in FIG. 13. The surgeon is able to feel the proximal end of tubular element 12 to indicate the exact location of the Umbilicus 44, which lies beneath the Abdominal Flap 50. The new site of the umbilical orifice is located exactly by excavation of the tubular element 12 through the Abdominal Flap 50. Once the excavating incision is made, the proximal end of the tubular element 12 is exposed and protrudes through the new umbilical orifice (not shown).

In FIG. 14, there is shown another embodiment of a plunger type, suture shuttle element 314. Suture shuttle element 314 has affixed to the top thereof a plunger type, circular knob 326. A tubular body portion 327 is connected on one end to the circular knob 326 and on the other to a set of ribbed portions 328 which in turn are connected to an end plate 330 on the other. The tubular body portion 327 and the ribbed portions 328 have an outside diameter of approximately the same dimension as the inside diameter of tubular element 12. End plate 330 contains notches 332 spaced in opposing quadrants. Notches 332 are angled upward toward circular knob 326. Terminal of notches 332, proximate interior of ribbed portions 328 are eyelets 333. Eyelets 333 are adapted to receive suture material 334 as shown, such that as the suture shuttle element 314 is draw upward through the tubular element 12 (112) as previously described, the suture material 334 is allowed to slip there through. The ribbed portions 328 are adapted for guiding suture shuttle element 314 through the opening in tubular element 12 (112, 312).

Turning to FIG. 17, there is shown another embodiment of the Umbilicus shield having an adjustable, telescoping tubular element 312. Telescoping tubular element 312 has a base element 316 and a locking element 317, which telescopes within base element 316, and can be locked in a ridged position, as will be further described below. Base element 316, as shown in FIG. 15, contains a horizontal channel 318 which communicates with the lip 319 of base element 316 and has disposed therein locking notches 320. The Umbilicus shield is adjustable and telescoping so that the shield can be easily adjusted to the patient's panniculus of fat which is to be navigated during umbiliplasty.

Telescoping tubular element 312 is of sufficient inside diameter to house the Umbilicus when the telescoping tubular element 312 is tensioned in place. Disposed upon base element 316, at its proximal end, are notches 322 and 324, respectively, for releasably, frictionally engaging suture material 334. Advantageously, base element 316 contains marking on the outer diameter, at the proximal end, as shown, indicating UP, DOWN, LEFT (“L”), and RIGHT (“R”). The UP and DOWN nomenclature are advantageously coincident with notches 324 and 322, respectively.

Turning to FIG. 16, there is shown a locking element 317 having an outside diameter slightly less than inside diameter of base element 316 and having an upstanding pin or key 321 which is adapted to matingly engage locking notches 320 as better shown in FIG. 17.

As better seen in FIG. 17, the adjustable, telescoping tubular element 312 comprising locking element 317 slidingly inserted into base element 316 is shown. In this manner, telescoping tubular element 312 is able of various lengths depending upon the surgical requirements and, specifically, the abdominal fatty tissue present during Circum-Umbilical Pedicle Dissection. In operation, locking element 317 containing pin 321 is inserted into base element 316 such that pin 321 resides in horizontal channel 318 by means of the opening in lip 319. Once pin 321 is inserted a distance to engage a locking notch 320, locking element 317 is twisted counter clockwise such that pin 321 engages a locking notch 320 to present a ridged telescoping, tubular element 312, as shown in FIG. 17.

As further shown in FIGS. 15 and 17, the base element 316 can be of varying lengths depending upon the application. As shown, the base element 316 depicted in FIG. 15, is longer than that depicted in FIG. 17. It will be realized by those skilled in the art that a number of telescoping, tubular elements are available to be used in accordance with the instant system. Spring loaded devices for retaining, for example, a pin or a ball in a detent or circular locking notch, and the like, are well known in the art and available for use in accordance with the system. However, since the system may be used in a human surgical setting, the telescoping, tubular element, including the base element and the locking element, must be capable of being readily sterilized by, for example, an autoclave.

The operation of the device for Umbilicus protection during abdominal surgery involves placing the entire stalk of the Umbilicus within the tubular element. The tacking stitches are advantageously taken at the outer circumference of the Umbilicus: one in the UP or 12:00 o'clock position and the other in the DOWN or 6:00 o'clock position. Thus, one is inserted subcutaneously in the Umbilicus at the point, which marks superior aspect of the midline on the Umbilicus; and, the second is taken subcutaneously in the bottom at the point which marks the inferior aspect of the midline on the Umbilicus. The suture material needs to be of sufficient length to protrude the length of the tubular element to be releasabley retained in the tubular element notches near the proximal end of the tubular element as previously described. Advantageously, the suture material should be of a length at least twice that of the length of the tubular element. The two tacking stitches, located subcutaneously in the superior and the inferior point of the midline on the Umbilicus, are then secured to the suture shuttle element, which has been inserted into the cylindrical housing of the tubular element, as previously described. The distal end of the cylindrical housing of the tubular element is then placed into to the circum umbilical incision performed earlier and pushed down with the index and thumb and at the same time keeping both tacking stitches in tension. This maneuver pulls the Umbilical Pedicel up and pushes the tubular element down while isolating the pedicle inside the tubular element with the abdomen skin still attached.

In one embodiment, tacking stitches are taken prior to dissection, and the suture material is used to secure the Umbilicus for umbilical dissection. In accordance with the embodiment where the tubular element contains the ring shaped electrocautery blade, the Umbilical Pedicel is dissected through the subcutaneous fat to the abdominal fascia. Once the tacking stitches are in place and the Umbilical Pedicel dissected, the suture shuttle element is placed into and through the tubular element, such that the distal end of the suture shuttle element protrudes the distal end of the tubular element. The suture material is then affixed to the distal end of the suture shuttle element as previously described and drawn by means of extraction of the suture shuttle element through the interior of the tubular element. In the embodiment wherein the tubular element contains the ring shaped electrocautery blade, the suture material is first drawn through the tubular element prior to Umbilical Pedicel dissection, energy source is attached to electrocautery circular shaped blade and energized such that pressure on the proximal end and ears of the tubular element dissects the Umbilical Pedicel to the abdominal fascia.

Once the distal end of the tubular element is secured against the abdominal fascia, the suture material tacked at the 12:00 o'clock position is secured under tension to the notch in the proximal end of the tubular element marked UP and the suture material tacked at the 6:00 o'clock position is secured under tension to the notch in the proximal end of the tubular element marked DOWN. It will be realized by the skilled artisan that, if necessary, a second set of tacking sutures can be secured to the left (3:00 o'clock) and right (9:00 o'clock) positions of the Umbilical Pedicel and secured, under tension, to corresponding notches at the corresponding positions in the proximal end of the tubular element.

The presence of the tubular element secured, as previously described, protects the Umbilical Pedicel from “excessive defattening” during circum Umbilical Pedicel dissection down to the abdominal fascia. Once the device is secured against the abdominal fascia, the lower abdominal incision and dissection of the Abdominal Flap is accomplished. The tubular element housing protects the stalk of the Umbilical Pedicel from nicking or amputation during Abdominal Flap undermining around the Umbilical Pedicel using blade or scissors.

An exemplary procedure includes a circum umbilical incision of about 3-5 mm deep. Then two, 2/0 Ethibond® tacking stitches are placed at the superior and inferior position in the Umbilicus. The suture material is fastened to the distal end of the suture shuttle element, which has been inserted into the tubular element, and the suture material is withdrawn through the opening in the tubular element. As previously described, the distal end of the tubular element is then placed into to the circum umbilical incision performed earlier and pushed down with the index finger and thumb and at the same time keeping both tacking stitches in tension.

A straight down dissection of the Umbilicus and its pedicle is preformed around the outer circumference of the tubular element while keeping pressure on placement of the tubular element with the index finger and thumb. The dissection is performed with scissor or electrocautery knife straight down on the outer wall of the tubular element. During this dissection, the tubular element moves down to the abdomen fascia, and protects the Umbilical Pedicel from bum or mechanical damage as well as from excessive “defattening.” The tacked superior suture material is then fixed in a notch on the tubular element, marked UP, at the same time pushing the tubular element down. The same maneuver is accomplished with the inferior suture material fixing it in the second notch of the tubular element, marked DOWN.

The tubular element, which now protrudes through the Abdominal Flap and through the subcutaneous fat to the abdominal fascia, is under constant pressure downward due to the secured tacking suture material, while constantly pulling the stalk of the Umbilicus up inside the tubular element. Thus, the Umbilical Pedicel, inside the tubular element, is completely isolated and protected. Any type of dissection can now be performed around the Umbilical Pedicel.

The lower abdominal incision is made and Abdominal Flap is elevated. Dissection of the Abdominal Flap using electrocautery knife around the protected Umbilical Pedicel is performed. The Umbilical Pedicel is protected and secured by the tubular element, preventing cutting of the Umbilical Pedicel. The Abdominal Flap is elevated over the tubular element leaving the tubular element secured to the abdominal fascia (wall) by means of the tacking suture material. The tubular element protects the Umbilical Pedicel from strangulation by sutures during musculoaponeurotic plication stage of the abdominoplasty.

When the Abdominal Flap is “re-draped,” the excess skin, including the old umbilical orifice, is excised at the lower abdominal incision with tension on the abdominal flap. The tubular element helps to determine the correct new umbilical orifice positioning during Umbilicus transportation by indicating the exact location of the Umbilicus, which lies under the abdominal flap. The tubular element proximal end opening corresponds with the location of the orifice on the abdomen skin. Markings are made on the abdomen skin accordingly. The new site of the umbilical orifice is located exactly by excavation of the proximal end of the tubular element.

The excess skin and fat is excised. The proximal end of tubular element (with protected Umbilical Pedicel inside) is exposed by applying a downward pressure on the skin proximate the new Umbilical site. The tubular element then “pops-out” through the incision in abdomen skin. During the suturing of the new Umbilical position, the sutures in notches (UP and DOWN markings on the tubular element) positioned at 12 and 6 o'clock and sides tubular element's markings R and L located on the tubular element at 9 and 3 o'clock position prevent and protect the Umbilical Pedicel from twisting and as a consequence from strangulation and necrosis.

All of the devices and systems disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices of this system have been described in terms of embodiments, it will be apparent to those of skill in the art that variations may be applied to the devices and systems described herein without departing from the concept, spirit, and scope of the invention. Various substitutions can be made to the systems described without departing from the spirit of the invention. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the invention as defined by the appended claims. 

1. A device for protecting the umbilicus during subcutaneous abdominal surgery comprising: an umbilicus shield including an open-ended vessel having a distal end and a proximal end, wherein the proximal end is adapted for encapsulating the umbilicus within the proximal end of the vessel; and, at least a pair of retaining means, deposed proximate the proximal end, for releasably retaining tacking sutures drawn through the open-ended vessel for drawing the umbilicus within the proximal end of the vessel.
 2. The device of claim 1 wherein the open-ended vessel is a tubular element; and, wherein the means for releasably retaining suture material is at least a pair of notches disposed in a lip on the proximal end of the open-ended vessel.
 3. The device of claim 1 further comprising a suture shuttle element, for slidable insertion into the open-ended vessel, having a proximal end and a distal end wherein the suture shuttle element contains, proximate its distal end, means for releasably retaining the tacking sutures.
 4. The device of claim 3 wherein the means for releasably retaining the tacking sutures comprises at least a pair of notches.
 5. The device of claim 2 wherein the tubular element has an upstanding collar portion disposed upon the proximal end of the tubular element and the notches are disposed in the upstanding collar portion.
 6. The device of claim 2 wherein the tubular element has opposing ears disposed peripherally of the proximal end of the tubular element and the notches are disposed in the opposing ears.
 7. The device of claim 2 wherein the tubular element is adjustable and telescoping including a base element and a locking element which cooperate such that the tubular element can be adjusted to the patient's panniculus of fat.
 8. The device of claim 7 wherein the base element includes a channel containing locking notches; and, the locking element includes a locking pin on the outer surface thereof for releasably matingly engaging the locking notches.
 9. The device of claim 2 wherein the tubular element contains, on the proximal outer surface thereof, markings in relationship to such notched portions to orient the tubular element, relative to the notches.
 10. The device of claim 9 wherein the markings are black printed “UP” and “DOWN”, R (right) and L (left) wherein each is disposed in each quadrant of the tubular element, wherein UP marks the superior (upper) aspect of the midline on the patient; and, DOWN marks the inferior (bottom) aspect of the midline of the patient.
 11. The device of claim 3 wherein the suture shuttle element contains, atop its proximal end a plunger type circular knob; and, proximate its distal end a plate in which the means for releasably retaining the tacking sutures is disposed.
 12. The device of claim 3 wherein the suture shuttle element contains, atop its proximal end a plunger type circular knob; and, proximate its distal end slanted notches containing eyelets interior thereof to allow the tacking sutures to slip there through.
 13. A system for protecting the umbilicus during subcutaneous abdominal surgery comprising: a.) an umbilicus shield including an open-ended vessel having a distal end and a proximal end, wherein the proximal end is adapted for encapsulating the umbilicus within the proximal end of the vessel during the subcutaneous abdominal surgery; and, at least a pair of retaining means deposed proximate the proximal end for releasably retaining tacking sutures drawn through the open-ended vessel for drawing the umbilicus within the proximal end of the vessel; and, b.) a suture shuttle element, for slidable insertion into the open-ended vessel, having a proximal end and a distal end wherein the suture shuttle element contains, atop its proximal end a plunger type circular knob; and, proximate its distal end at least a pair of retaining notches for releasably retaining the tacking sutures.
 14. The system of claim 13 wherein the open-ended vessel is a tubular element, and; wherein the means for releasably retaining the suture material is at least a pair of notches disposed in a lip on the proximal end of the open-ended vessel.
 15. The system of claim 13 wherein the retaining notches contain eyelets interior thereof to allow suture material to slip there through.
 16. The system of claim 14 wherein the tubular element has an upstanding collar portion disposed upon the proximal end of the tubular element and the notches are disposed in the upstanding collar portion.
 17. The system of claim 14 wherein the tubular element has opposing ears disposed peripherally of the proximal end of the tubular element and the notches are disposed in the opposing ears.
 18. The system of claim 14 wherein the tubular element is adjustable and telescoping including a base element and a locking element which cooperate such that the tubular element can be adjusted to the patient's panniculus of fat which must be navigated during umbiliplasty.
 19. The system of claim 18 wherein the base element includes a channel containing locking notches; and, the locking element includes a locking pin on the outer surface thereof for releasably matingly engaging the locking notches.
 20. A system for protecting the umbilicus during umbiliplasty comprising: a.) an umbilicus shield including an open-ended a tubular element having a distal end and a proximal end, wherein the proximal end is adapted for encapsulating the umbilicus within the proximal end of the vessel during the subcutaneous abdominal surgery; and, at least a pair of notches disposed in the proximal lip of the open-ended vessel for releasably retaining tacking sutures drawn through the open-ended vessel for drawing the umbilicus within the proximal end of the vessel; and, b.) a suture shuttle element, for slidable insertion into the open-ended vessel, having a proximal end and a distal end wherein the suture shuttle element contains, atop its proximal end a plunger type circular knob; and, proximate its distal end at least a pair of retaining notches having eyelets interior thereof to allow suture material to slip there through.
 21. The system of claim 20 wherein the tubular element is adjustable and telescoping including a base element and a locking element which cooperate such that the tubular element can be adjusted to the patient's panniculus of fat which must be navigated during umbiliplasty.
 22. The system of claim 21 wherein the base element includes a channel containing locking notches; and, the locking element includes a locking pin on the outer surface thereof for releasably matingly engaging the locking notches. 